BioSpace
Associate Engineering Fellow, Combination Product Development
BioSpace, Lexington, Massachusetts, United States, 02173
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Associate Engineering Fellow, Combination Product Development
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BioSpace Job Description
The Associate Engineering Fellow will lead Takeda’s cross‑functional combination product development efforts for use in clinical studies and for commercial release. The ideal candidate will be a hands‑on technical leader, considered a combination device subject matter expert (SME), providing project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for drug delivery systems. Areas of focus will include translating user needs to product requirements and specification development, feasibility test development, in‑silico development, design verification and validation testing, risk assessments, DHF creation, regulatory submission authoring, general project team technical support, and extensive collaboration with both internal and external partners. The individual is an expert in an Engineering Discipline in its entirety and is able to lead two or more programs in parallel. Accountabilities
Manage and provide project and technical leadership to cross‑functional teams for projects through clinical development, product registration and launch‑readiness. Will have technical responsibility for multiple projects. Establish and maintain the DHF, associated project plans, assess and mitigate technical risks and recommend or implement contingency plans as required. Lead the project execution in compliance with design control SOP. Oversee technical aspects of the development process including pertinent DHF deliverables, statistically sound design verification protocols/reports, design validation activities, and support production of materials for Clinical and Human Factors studies. Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. Support the optimization of design control elements to comply with combination product/medical device regulations. Lead or assist in deviation, complaint and failure investigations. Author regulatory Common Technical Document (CT) to support submission. Mentor engineering staff within and outside of own discipline. Generate and present technical information to multidisciplinary audiences (internal/external) and at various levels. Education, Experience & Skills
A Bachelor of Science degree in Engineering is required; a Master of Science is preferred. Bachelor’s degree with 15+ years relevant experience; Master’s with 13+ years or PhD with 7+ years, preferably within the biopharmaceutical industry or medical device development and commercialization. Minimum of 7 years cross‑functional leading teams and projects. Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820), ISO13485, IEC 62304 and ISO14791 requirements. Proven track record of developing and gaining regulatory approval of medical devices and/or drug delivery systems. Experience with combination products requiring reconstitution and/or use of ancillary delivery solutions; large volume technology experience is highly desirable. Experience with in‑silico development is highly desirable. Strong collaboration, proven technical leadership and conflict resolution skills with a track record of delivering products to the market. Design for Six Sigma (DFSS) certification is desirable. Prior experience leading projects that include managing external design, development, and manufacturing partners. Knowledge of process validation and design transfer preferred. Knowledge & Skills
Strong knowledge of developing and commercializing FDA regulated devices/combination products under Design Control regulations and ISO 14971. Extensive knowledge of engineering principles, concepts and applications. Working knowledge of ISO 11608‑1, IEC 60601‑1 and related standards. Ability to lead as well as support as a technical individual contributor. Strong planning and organizational skills. Excellent writing and oral communication skills. Knowledge of project management techniques, tools and metrics; aptitude for project foresight and contingency planning. Ability to mentor technical and cross‑functional team members. Strong collaboration skills with external partners. Travel Requirements
May require approximately 10% travel. Line Function Specific Qualifications
Provide technical leadership on multiple projects in parallel as well as across the organization. Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward. Identify, communicate and lead device design control process evolution to meet device regulations. Collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement. Work closely with external design, development, and manufacturing partners. Interact with external partners including testing laboratories, CROs and CMOs. Compensation and Benefits
U.S. Base Salary Range: $153,600.00 - $241,340.00. Eligible for short‑term and long‑term incentives. U.S. based employees may receive medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation. Location: Lexington, MA Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Associate Engineering Fellow, Combination Product Development
role at
BioSpace Job Description
The Associate Engineering Fellow will lead Takeda’s cross‑functional combination product development efforts for use in clinical studies and for commercial release. The ideal candidate will be a hands‑on technical leader, considered a combination device subject matter expert (SME), providing project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for drug delivery systems. Areas of focus will include translating user needs to product requirements and specification development, feasibility test development, in‑silico development, design verification and validation testing, risk assessments, DHF creation, regulatory submission authoring, general project team technical support, and extensive collaboration with both internal and external partners. The individual is an expert in an Engineering Discipline in its entirety and is able to lead two or more programs in parallel. Accountabilities
Manage and provide project and technical leadership to cross‑functional teams for projects through clinical development, product registration and launch‑readiness. Will have technical responsibility for multiple projects. Establish and maintain the DHF, associated project plans, assess and mitigate technical risks and recommend or implement contingency plans as required. Lead the project execution in compliance with design control SOP. Oversee technical aspects of the development process including pertinent DHF deliverables, statistically sound design verification protocols/reports, design validation activities, and support production of materials for Clinical and Human Factors studies. Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. Support the optimization of design control elements to comply with combination product/medical device regulations. Lead or assist in deviation, complaint and failure investigations. Author regulatory Common Technical Document (CT) to support submission. Mentor engineering staff within and outside of own discipline. Generate and present technical information to multidisciplinary audiences (internal/external) and at various levels. Education, Experience & Skills
A Bachelor of Science degree in Engineering is required; a Master of Science is preferred. Bachelor’s degree with 15+ years relevant experience; Master’s with 13+ years or PhD with 7+ years, preferably within the biopharmaceutical industry or medical device development and commercialization. Minimum of 7 years cross‑functional leading teams and projects. Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820), ISO13485, IEC 62304 and ISO14791 requirements. Proven track record of developing and gaining regulatory approval of medical devices and/or drug delivery systems. Experience with combination products requiring reconstitution and/or use of ancillary delivery solutions; large volume technology experience is highly desirable. Experience with in‑silico development is highly desirable. Strong collaboration, proven technical leadership and conflict resolution skills with a track record of delivering products to the market. Design for Six Sigma (DFSS) certification is desirable. Prior experience leading projects that include managing external design, development, and manufacturing partners. Knowledge of process validation and design transfer preferred. Knowledge & Skills
Strong knowledge of developing and commercializing FDA regulated devices/combination products under Design Control regulations and ISO 14971. Extensive knowledge of engineering principles, concepts and applications. Working knowledge of ISO 11608‑1, IEC 60601‑1 and related standards. Ability to lead as well as support as a technical individual contributor. Strong planning and organizational skills. Excellent writing and oral communication skills. Knowledge of project management techniques, tools and metrics; aptitude for project foresight and contingency planning. Ability to mentor technical and cross‑functional team members. Strong collaboration skills with external partners. Travel Requirements
May require approximately 10% travel. Line Function Specific Qualifications
Provide technical leadership on multiple projects in parallel as well as across the organization. Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward. Identify, communicate and lead device design control process evolution to meet device regulations. Collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement. Work closely with external design, development, and manufacturing partners. Interact with external partners including testing laboratories, CROs and CMOs. Compensation and Benefits
U.S. Base Salary Range: $153,600.00 - $241,340.00. Eligible for short‑term and long‑term incentives. U.S. based employees may receive medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation. Location: Lexington, MA Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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